BOA VISION Flexible Sensor-Ureterorenoscope Instructions for Use

Important general notes and instructions Make sure that this product is used only as intended and described in this instruction manual and by adequately trained and qualified medical personnel, Maintenance and repair must be carried out by authorized experts. Use the product only in the combinations and with the accessories and spare parts specified in this instruction manual. Use other combinations, accessories and replacement parts only if they are expressly intended for the planned appli­ cation and if the performance characteristics and safety requirements are met. The product must not be altered in any way. This manual is an integral part of the product and must be stored in such a way that it is accessible at any time during its entire life cycle. This manual must be passed on to any subsequent owner or user. Immediately upon receipt, check the product and its accessories for completeness and possible damage. Should the shipment give rise to complaints, please inform the manufacturer or supplier immediately. Subject to technical changes! Due to ongoing developments the illustrations and technical data may deviate slightly. CAUTION! Federal law restricts this device to sale by or on the order of a physician.

Safety instructions and levels of danger Symbol

Level of danger

WARNING!

Failure to observe can result in death or extremely serious injuries.

CAUTION!

Failure to observe can result in slight injury or damage to the product.

. .

0

IMPORTANT!

Failure to observe can result in damage to the product or surroundings.

NOTE!

User tips for optimum device use and other useful information. GERMANY RICHARD WOLF GmbH 75438 Knittlingen Pforzheimerstr. 32 Telephone: +49 70 43 35-0 Telefax: +49 70 43 35-4300 MANUFACTURER [email protected] www.richard-wolf.com

USA RICHARD WOLF Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Toll Free: 001 (800) 323 - 9653 Phone: 001 (847) 913 - 1113 Fax: 001 (847) 913 - 1488 [email protected] www.richardwolfusa.com

UK RICHARD WOLF UK Ltd. Waterside Way Wimbledon SW17 0HB Telephone: + 44 20 89 44 74 47 Telefax: + 44 20 89 44 13 11 [email protected] www.richardwolf.uk.com

BELGIUM / NETHERLANDS N.V. Endoscopie RICHARD WOLF Belgium S.A. Industriezone Drongen Landegemstraat 6 9031 Gent Drongen Telephone: +32 92 80 81 00 Telefax: +32 92 82 92 16 [email protected] www.richard-wolf.be

FRANCE RICHARD WOLF France S.A.R.L. Rue Daniel Berger Z.A.C. La Neuvillette F-51100 Reims Telephone: +33 3 26 87 02 89 Telefax: +33 3 26 87 60 33

AUSTRIA RICHARD WOLF Austria Ges.m.b.H. Wilhelminenstraße 93 a A-1160 Vienna Telephone: +43 14 05 51 51 Telefax: +43 14 05 51 51 45

[email protected]

[email protected] www.richard-wolf.com

Marketing Office U.A.E RICHARD WOLF Middle East P.O. Box 500283 AL Thuraya Tower 1 9th Floor, Room 904, Dubai Telephone: + 9 71 43 68 19 20 Telefax: + 9 71 43 68 61 12 [email protected] www.richard-wolf.com

INDIA RICHARD WOLF India Private Ltd. JMD Pacific Square No. 211 A, Second Floor Behind 32nd Milestone Gurgaon - 122 001 National Capitol Region Telephone: + 91 12 44 31 57 00 Telefax: + 91 12 44 31 57 05 [email protected] www.richard-wolf.com

GA-D396

Contents 1

Technical description...

1

2

Indications for use...

1

3

Indications and field of use...

1

4 4.1 4.2

Contraindications and side effects... Contraindications... Side effects...

2 2 2

5 5.1 5.1.1 5.2

Combinations... Compatibility of BOA vision and camera controller... Electromagnetic compatibility (EMC) - IEC 60601-1-2 : 2014... Compatibility of BOA vision and accessories...

2 3 3 5

6 6.1 6.2

Illustration... Legend and identification... Symbol...

6 7 8

7 7.1 7.2 7.2.1 7.2.2 7.3 7.4 7.5 7.5.1 7.5.2 7.5.3 7.5.4 7.6 7.7 7.8 7.8.1 7.8.2

Use... Assignment of function keys (15)... Preparation... Adapter (8) (option)... Biopsy valve cpl. (9) (option)... Installing/removing the plug protection cap (14.2)... Connecting the URS to the camera controller... Additional notes and instructions for use... Deflecting the instrument tip (4)... Light... Electrical current... Image quality... Laser application... HF applications... Auxiliary instruments and endoscopic accessories... Inserting flexible auxiliary instruments... Inserting the URS via a guide wire...

9 10 10 10 11 12 13 14 15 15 16 16 16 17 17 17 18

8 8.1 8.2 8.2.1 8.2.2 8.3

Checks... Visual check... Function check... Adapter (8) (option)... BOA vision... Carrying out a manual leakage test...

19 19 20 20 20 22

9 9.1 9.2 9.3 9.4 9.5 9.5.1 9.6

Processing and maintenance... Flowchart of the processing process „BOA vision“... Auxiliary resources required... Channel connections... Remove/discard products before processing... Processing procedure... Processing procedure „BOA vision“... Flowchart of the processing process „Accessories“...

23 23 24 25 25 26 27 35

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I

9.7 9.7.1 9.8

Auxiliary resources required... 36 Processing procedure „Accessories“... 37 Processing in case of repair... 40

10

Technical data and order data... 41

11

Spare parts and accessories... 41

12 12.1

Operating, storage, transport and shipping conditions... 43 Disposal of product, packaging material and accessories... 43

13

Warranty and Customer Service... 44

II

GA-D396

1

Technical description

The Sensor-Ureterorenoscopes BOA vision (single channel) comprise the following: Z Flexible insertion sheath Z Control housing with control lever (with integrated position lock for 0 position) Z Proximal, fixed supply cable with camera connector Z Deflectable instrument tip +270°/-270° Z Function keys on the handle Z Integrated image sensor in the instrument tip Z Integrated LED illumination in the handle Z Working channel with biopsy port at 45 with two luer connectors Accessories Z Adapter (option) Z Biopsy valve cpl. (option) Z Universal sealing valve 1-6 Fr. (option) (single-use item) In this manual, the Sensor-Ureterorenoscopes BOA vision will in the following be called BOA vision or URS.

2

Indications for use

The flexible Sensor-Ureterorenoscopes BOA are used for visualizing body cavi­ ties and organs via natural and surgically created passages. These products are exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately instructed persons.

3

Indications and field of use

For examination, diagnostics and/or therapy in conjunction with endoscopic acces­ sories. The product is used in the following disciplines: Z Urology ' urinary tract ' nephroscopy

CAUTION! Caution if video signal processing fails! This may delay or stop the operation. There must always be an operable comparable device or a conventional system on hand, so that the user can complete the operation if the video image or LED illumination fails.

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1

4

Contraindications and side effects

4.1

Contraindications

4.2

Side effects

5

Combinations

Contraindications directly related to the product are presently unknown. On the basis of the patient's general condition the doctor in charge must decide whether the planned use is possible or not. For further notes and instructions please refer to the latest medical literature. No side effects are to be expected if the system is used as intended. BOA vision is used in conjunction with: Z ENDOCAM LOGIC 5525 Camera Controllers ' LOGIC HD 552510x ' LOGIC HD LITE 5525201 ' LOGIC 4K 5525301 Z Suction and irrigation devices Z Lasers Z Endoscopic accessories, e.g. ' Flexible forceps ' Laser fibers ' Stone baskets ' etc.

CAUTION! Do not combine products incorrectly! Injuries of the patient, user or others as well as damage to the product are possible. Combine the different products only if their intended uses and relevant technical data (working length, diameter, etc.) are the same. Follow the instruction manuals of the products used in combination with this product.

2

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5.1

Compatibility of BOA vision and camera controller

.

IMPORTANT! BOA vision are only compatible with the following Richard Wolf ENDOCAM LOGIC 5525 Camera Controllers: ' LOGIC HD 552510x: from software version R12. Follow the instruction manual GA-A282 ' LOGIC HD LITE 5525201: from software version R12. Follow the instruction manual GA-A293 ' LOGIC 4K 5525301: no limitation. Follow the instruction manual GA-A336 Richard Wolf camera controllers with a lower software version can be retrofitted using a software update.

.

NOTE! If a software update of a Richard Wolf camera controller is required, please con­ tact our customer service department. RICHARD WOLF Service www.richard-wolf.com/en-us/service-and-service-packages/

5.1.1

Electromagnetic compatibility (EMC) - IEC 60601-1-2 : 2014

The device/system, in the following referred to as product, was tested in combination with Richard Wolf ENDOCAM LOGIC 5525 Camera Controllers (LOGIC HD 552510x, LOGIC HD LITE 5525201 and LOGIC 4K 5525301).

Guidelines and manufacturer's declaration - Electromagnetic emissions The product is intended for use in the environment specified below. The user must assure that the product is used in such an environment. Emissions measurement / test

Compliance

Electromagnetic environment - Guidelines

HF emissions to CISPR 11

Group 1

The product uses HF energy for its internal function. The HF emission level is extremely low and it is not likely to cause any interference in nearby electronic equipment.

HF emissions to CISPR 11

Class B

Harmonic emissions to IEC 61000-3-2

Class A

In conformity with IEC 61000-3-3 “Emission of voltage fluctuations / flicker"

The product is suitable for use in all establishments, including domestic establishments. This also includes establishments directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.

Guidelines and manufacturer's declaration - Electromagnetic immunity The product is intended for use in the environment specified below. The user must assure that the product is used in such an environment. Immunity tests

IEC 60601 test level

Compliance

Electromagnetic environment - Guidelines

Electrostatic discharge (ESD) to IEC 61000-4-2

 8 KV contact discharge  15 KV air discharge

Yes

Floors should be wood, concrete or ceramic tile. With floors made of synthetic material, the relative humidity of the ambient air must be at least 30%.

Electrical fast transience, bursts to IEC 61000-4-4

 2 KV for power supply lines  1 KV for input and output lines

Yes

Mains/line power quality should be that of a typical commercial or hospital environment.

Surge voltage (surges) to IEC 61000-4-5

 1 KV line to line voltage  2 KV line to ground voltage

Yes

Mains/line power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and sup­ ply voltage variations to IEC 61000-4-11

0% UT * ; 1/2 period at 0.45, 90, 135, 180, 225, 270 and 315 degrees 0% UT * ; 1 Period and 70% UT * ; 25/30 Periods single-phase: at 0 degrees

Yes

Mains/line power quality should be that of a typical commercial or hospital environment. If the user of the product requires continued operation during power mains/line interruptions it is recommended that the product be powered from an uninterrupt­ ible power supply or battery.

Power frequency (50/60 Hz) magnetic field, to IEC 61000-4-8

30A/m

Yes

Power frequency magnetic fields should be at lev­ els characteristic of a typical location in a commer­ cial or hospital environment.

* NOTE! UT is the line / mains voltage prior to application of the test level.

GA-D396

3

Guidelines and manufacturer's declaration - Electromagnetic immunity for products that are not life-supporting The product is intended for use in the environment specified below. The user must assure that the product is used in such an environment. Immunity tests

IEC 60601 test level

Compliance

Electromagnetic environment - Guidelines Portable and mobile RF communications equipment should be used no closer to any part of the product, including ca­ bles, than the recommended separation distance calculated from the equation applicable to the frequency of the transmit­ ter. Recommended separation distance: d = 1.2 p P d = 1.2 p P for 80 MHz to 800 MHz

Conducted HF interference to IEC 61000-4-6

6 Vrms 150 kHz to 80 MHz

Yes

Radiated HF interference to IEC 61000-4-3

3 V/m 80 MHz to 2.7 GHz

Yes

d = 2.3 p P for 800 MHz to 2.5 GHz P = Nominal power output rating of the transmitter in watts (W) (according to the transmitter manufacturer)

d = recommended separation distance in meters (m) Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey1, should be less than the compliance level in each frequency range2. Interference may occur in the vicinity of devices with the following symbol:

REMARKS: At 80 MHz and 800 MHz the higher frequency range applies. These guidelines may not apply in all situations. The propagation of electromag­ netic waves is affected by absorption and reflexion from buildings, objects and people. 1 = The field strength of stationary transmitters (e.g. base station for radio phone, earth to earth radio stations,, amateur radio stations, radio and television transmitters) cannot be exactly predicted in theory. To assess the EMC environment due to fixed transmitters an electromagnetic site survey should be conducted. If the measured field strength in the location in which the product is used exceeds the applicable compliance level above, the product should be observed to verify normal operation. If abnormal performance is observed, additional measures may be required, such as reorienting or relocating the product. 2 = Over the frequency range between 150 kHz and 80 MHz the field strength should be below 3 V/m.

Recommended separation distances between portable and mobile HF telecommunication devices and devices which are not life-supporting The product is intended for use in an electromagnetic environment where HF disturbances are controlled. The user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile HF telecommunica­ tions equipment and the product. Separation distance as a function of transmitter frequency (m) Rated nominal output power of thetransmitter (W)

150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

d = 1.2 p P

d = 1.2 p P

d = 2.3 p P

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

For transmitters rated at a nominal output power not listed in the table above, the recommended separation distance (d) in meters (m) can be determined using the applicable equation (observe frequency). P = nominal power of the transmitter in Watts (W). REMARKS: At 80 MHz and 800 MHz the higher frequency range applies. These guidelines may not apply in all situations. The propagation of electromag­ netic waves is affected by absorption and reflexion from buildings, objects and people.

4

GA-D396

WARNING! Device operation may be jeopardized by other devices located in the immediate vicinity or if devices are stacked. Other devices located in the immediate vicinity or stacked devices may interfere with each other and cause malfunctions, in particular if devices give off energy (e.g. HF surgical devices). If devices have to be arranged in this way, make sure that the devices work properly. WARNING! Safety distance from portable HF communication devices. Medical electrical devices can be influenced by mobile HF communication de­ vices. Do not operate HF communication devices in the immediate vicinity of medical electrical devices. Non-compliance can cause the power characteristics of the device to be impaired. WARNING! Influence on interference immunity and interference emission. Use only accessories or cables specified or supplied by the manufacturer. Other accessories and cables can cause increased electromagnetic interference or a reduced electromagnetic immunity of the device and lead to malfunctions. CAUTION! The product is intended to be used in professional healthcare facility environment but exclude medical treatment areas with high powered medical electrical equip­ ment e.g. ' HF surgery ' MR system (Magnetic resonance imaging) ' CT system (Computer tomography) ' Diathermy

5.2

Compatibility of BOA vision and accessories Z Adapter (option) ' is used for inserting auxiliary instruments through the working channel ' is used for connecting suction and irrigation components Z Biopsy valve cpl. (option) ' provides a seal when inserting auxiliary instruments from 3-5 Fr. through the working channel Z Universal sealing valve 1-6 Fr. (option) (single-use item) ' is used for inserting auxiliary instruments from 1-6 Fr. through the working channel

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5

6

Illustration

8.4

8.4.1 8.4.2

8.4.3

8.4.4

2

8

3

10 9.3 9.2 9.1

7 6

1 3 4

11

8.3 8.2 8.1

6.1

9

#4

5

14

12 13

#5

#6

#7

14.2

14.1 15.2

#1

13 #3 #2

15

15.1

Fig. 1

6

GA-D396

6.1

Legend and identification Item

Designation

Item

Designation

1

Working channel

9

Biopsy valve cpl. (option)

2

Objective lens

9.1

Valve housing

3

Light exit

9.2

Sealing valve (single-use item)

4

Instrument tip, controllable

9.3

Valve cap

5

Flexible instrument sheath

10

Universal sealing valve 1-6 Fr (option) (single-use item)

6

Irrigation connector

11

Rubber cap

6.1

Luer sealing cap

12

Connector for leakage test and pressure equalization

7

Luer fitting

13

Control lever

8

Adapter (option)

14

Supply cable

8.1

Locking ring

14.1

Camera plug

8.2

Supply and drain stopcocks

14.2

Plug protection cap

8.3

Instrument port stopcock

15

Function keys

8.4

Stopcocks, with removable plug

15.1

Function key 1 (left)

8.4.1

Stopcock plug, complete

15.2

Function key 2 (right)

8.4.2

Stopcock housing

8.4.3

Luer fitting

8.4.4

Indication of passage on Stopcock housing/stopcock plug Follow the instruction manual

#

Further identifications:

#1

Product no.

#5

#2

CE 0124

#6

#3 #4

GA-D396

Deflection of instrument tip U = Up D = Down

Move the control lever to distal Move the control lever to proximal

#7

IPX7 (Protected against the effects caused by temporary immersion in water)

Recycle the product separately. Do not dis­ card together with other waste.

Working channel in Fr.

7

6.2

Symbol Symbol

Designation Follow the instruction manual Follow the manual

REF

Order number

SN

Series no.

LOT

Lot identification Manufacturing date Manufacturer Do not reuse Do not resterilize Number, amount Expiry date

STERILE EO Sterilized with ethylene oxide Do not use if package is damaged Keep away from sunlight XX° XX° XX%

Limitation of temperature Limitation of humidity

XX%

IPX7

Protected against the effects of temporary immersion in water. Recycle the product separately. Do not discard together with other waste.

Rx ONLY

Federal law restricts this device to sale by or on the order of a physician. Identification in conformity with Medical Product Directive 93/42/EEC, only valid if the product and/or the packaging is marked with this identification. Products of category IIa and above, as well as sterile products or products with measuring function of category I, are additionally marked with the code no. of the notified body (0124).

8

GA-D396

7

Use WARNING! Unsterile use of products can transmit diseases! The products are delivered unsterilized. To protect the patient, user and third par­ ties, the products must be processed in accordance with the manual ' prior the initial use ' before each subsequent use ' before return shipment Informations regarding the processing of the accessories ' see chapter 9.7 WARNING! Multiple use of disposable items! The service life of products marked as disposable, i.e. for single use only, has been designed for only one use in or on a single patient. Multiple uses can impair and or change the product properties and therefore endan­ ger the patient, user and others. Possible dangers / risk factors: ' Strength problems ' Severe impairment of the function ' Damage to the product ' Substantially increased risk of infection ' Biocompatibility problems In the case of multiple uses, the product responsibility lies with the user. In this case the manufacturer can no longer guarantee the safety and perfor­ mance of the product. WARNING! 24­hour multi­patient use! To ensure patient safety, only sterile fluids and sterile irrigation accessories, with device components that are used on a single procedure at a time should be used (e.g., 24­hour multi­patient use accessories are not recommended). CAUTION! The products have only limited strength! Excessive force will cause damage, impair the function and therefore endanger the patient. Make sure that no missing parts remain in the patient. Do not use the products if they are damaged or incomplete or have loose parts.

.

GA-D396

NOTE! When connecting the URS to the camera controller, white balance is never necessary. The configuration of illumination and image generation allows a one time white balance. This factory white balance is stored on the URS.

9

7.1

Assignment of function keys (15) Fig. 2

15.2

The function keys (15.1) (15.2) are predefined by the application profile set on the camera controller, but can be changed by the user at any time. For this applied part the “flex. SensorSCOPES“ application profile is recommended.

15

15.1 Fig. 2

7.2

Preparation

.

NOTE! The following products can be attached to the luer fitting (7): ' Biopsy valve cpl. (9) (option) ' Adapter (8) (option) ' Universal sealing valve 1-6 Fr. (10) (option) ' Other commercially available disposable (single-use) stopcocks and valves Z Immediately before and after each use, check the products for damage, loose parts and completeness. ' Carry out a check: see sections 8 and 8.1

7.2.1

Adapter (8) (option) Installing the adapter (8) 8.4.1

Fig. 3 Z Connect the stopcock plug (8.4.1). Z Place the rubber cap (11) onto adapter (8).

. 8

11

NOTE! Optionally, the biopsy valve cpl. (9) or the universal sealing valve 1-6 Fr. (10) can be installed instead of the rubber cap (11).

Fig. 3

10

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Fig. 4 Z Pull and hold the locking ring (8.1) as indicated by the arrow as far as it will go. Z Engage the luer fitting (7) in the slot of the locking ring (8.1) and let go of lock­ ing ring (8.1). ' The locking ring (8.1) must return to its home position. Z Close the irrigation connector (6) with a luer sealing cap (6.1).

6.1

7 8.1

6

Fig. 4 Connecting the supply and drain tubes Fig. 5 Z Connect the supply and drain tubes to the supply and drain stopcocks (8.2). Z Open the supply and drain stopcocks (8.2). Z Switch on the suction and irrigation system and check the suction and irrigation function. Z Check the entire system for leak-tightness and free passage (patency). Z Carry out a function check: see section 8.2

8.2

Fig. 5 7.2.2

Biopsy valve cpl. (9) (option)

9

9.3

6

7

6.1

Assembling the biopsy valve cpl. (9) (option) Fig. 6 Z Check assembly. ' See section 9.7.1, page 40 Z Screw on the valve cap (9.3) and tighten. Z Screw the biopsy valve cpl. (9) onto the luer fitting (7). Z Close the irrigation connector (6) with a luer sealing cap (6.1).

. NOTE! Fig. 6

GA-D396

Optionally, the universal sealing valve 1-6 Fr. (10) can be mounted to the biopsy valve cpl. (9).

11

Connecting the irrigation tube Fig. 7 Z Remove the luer sealing cap (6.1). Z Connect the irrigation tube to the irrigation connector (6). Z Switch on the irrigation system and check the irrigation function. Z Check the entire system for leak-tightness and free passage (patency).

10

6.1

6 Fig. 7 Z Carry out a function check: see section 8.2

7.3

Installing/removing the plug protection cap (14.2)

.

IMPORTANT! Place the plug protection cap (14.2) fully onto the camera plug (14.1) as shown in the figure. Holding the plug protection cap (14.2) by the sides facilitates the installation or removal.

14.2

Fig. 8

12

14.1

GA-D396

7.4

Connecting the URS to the camera controller

.

IMPORTANT! The supply cable has only limited strength. Applying excessive force or high mechanical loads can cause damage to the supply cable or wiring, resulting in image interference or image and illumination failure. Z Do not pinch, squeeze or excessively bend the supply cable. Z Do not pull on the supply cable.

Fig. 9

Fig. 10

14.2

Z Remove the plug protection cap (14.2) from the camera plug (14.1).

14.1

14

Fig. 10

GA-D396

13

Fig. 11 Z Switch on the camera controller. Z After the controller has booted connect the URS via the camera plug (14.1) to the camera controller ' LOGIC HD 552510x ' LOGIC HD LITE 5525201 ' LOGIC 4K 5525301 Z Select the “flex. SensorSCOPES“ application profile in the controller menu. ' For further information see GA-A282, GA-A293 and GA-A336

CAUTION! Danger of dazzling! Danger of impaired sight. Do not look into the light exit area of a URS connected to a camera controller.

14.1

Fig. 11

7.5

Additional notes and instructions for use CAUTION! Danger of transmitting microorganisms! To prevent contamination of the camera plug when disconnecting it from the camera controller during the course of an operation, install plug protection cap immediately after disconnecting the plug. A contaminated camera plug must be processed as described under section 9.5.1, page 29. Residual moisture in the contacts can impair signal transmission (e.g. interruptions, poor contacts). The plug protection cap remains in place during the entire reprocessing process. CAUTION! Limited strength of the URS! High forces and excessive mechanical loads can cause damage and impair the function. Do not kink the flexible instrument sheath and do not bend it to an excessively small radius (minimum 150 mm diameter) (Fig. 12).

Fig. 12

14

GA-D396

CAUTION! The deflectable instrument tip may be blocked due to external causes (such as limited free space)! This may damage the controls. If the instrument tip is blocked, do not use force when actuating the control lever. Z Move the instrument tip to a position that allows control without applying force. ' See section 7.5.1 7.5.1

Deflecting the instrument tip (4)

.

NOTE! The straight position of the instrument tip (4) (0° position) is indicated by a notch (snap in position) on the control lever, complete (13). Fig. 13 Deflecting (i.e. controlling, angling) the tip Z Actuate the control lever (13). Direction

Deflecting

Movement of control lever

up (U)

270

distally

down (D)

270_

proximally

up (U)

270

proximally

down (D)

270_

distally

Model 7355076, 7355076US 7355071, 7355071US

4 up proximally

down Fig. 13 7.5.2

distally

13

Light

WARNING! Intense heat due to high light energy! Danger of inadvertent tissue damage ' due to insufficient distance between the light exit area and the tissue ' due to soiling/contamination in the light exit area Do not touch the light exit area and avoid direct contact with the tissue. Follow the described instructions Z Remove any soiling. ' see section 8.2.2

WARNING! Fire hazard! When placing the endoscope onto heat-sensitive flammable surfaces (dark drapes etc.) the high light energy at the light exit area of the endoscope can cause high temperatures or even ignition. Store the endoscope in a safe place.

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15

7.5.3

Electrical current

.

IMPORTANT! Use only products with type BF applied parts in conjunction with the URS. WARNING! Danger of electric shock! Patient leakage currents can add up if the endoscopes are combined with other powered endoscopic accessories. Make sure that the combinations do not exceed the permissible patient leakage currents.

7.5.4

Image quality

CAUTION! Increased risk potential if the image is blurred! Danger of injuring the patient. Stop the intervention for safety reasons if the image is blurred. Z Before use, check the image quality of the URS. ' see section 8.2.2

7.6

Laser application

When applying a laser make sure you follow the laser device manufacturer's in­ structions as well as the general regulations on the use of lasers. Wear the required personal protection equipment.

CAUTION! Do not work outside the scope's field of view! Inadvertent tissue damage as well as damage to the distal end of the URS and to instrument parts is possible. Z Activate the laser only after ' the tip of the laser fiber is fully visible through the URS and ' the pilot beam makes contact with the area to be treated.

CAUTION! High temperatures due to highly coherent laser beam! The heat generated by the laser beam reduces the strength of instrument parts. Do not direct the laser beam at instrument parts, in particular not at plastic parts. Keep a safe distance. CAUTION! Danger of destroying the working channel by the sharp distal end of the laser fiber! The stronger (stiffer) the laser fiber the bigger the danger that the sharp distal end of the laser fiber destroys the working channel. Z The laser fiber must therefore be inserted in the working channel or retracted from the working channel, respectively, carefully and only with straight instru­ ment sheath and when the instrument tip is straight (0 position).

CAUTION! Danger of destroying the instrument by a broken laser fiber! If the instrument tip is angled (small bending radius) this increases the danger of a fracture of the laser fiber and even more so with increasing laser fiber diameter. A fracture of the laser fiber within the instrument channel while the laser energy is active will immediately destroy the instrument. In the latter case, switch off the laser energy immediately. When using highly flexible laser fibers with a maximum permissible laser fiber diameter of 365 m only a reduced deflection of the instrument tip is possible. CAUTION! Increased danger of laser fiber breakage if there is no protective coating or jacket! We recommend removing only 1 mm of the laser fiber jacket at the distal tip.

16

GA-D396